Berliner Tageszeitung - BioNxt Completes GMP Manufacturing and Submits Clinical Trial Application for Sublingual Cladribine Drug Candidate

Together, these achievements represent an important advancement toward BioNxt's planned first human clinical study. Building on the completion of the Investigational Medicinal Product Dossier ("IMPD") announced in August 2026, BioNxt has now entered the formal clinical trial authorization process while finalizing quality control testing and preparing for the formal release of the investigational medicinal product ("IMP"). Subject to regulatory authorization and completion of the remaining pharmaceutical quality requirements, the Company intends to proceed with a comparative human pharmacokinetic and bioequivalence study against Mavenclad®, the approved oral Cladribine tablet formulation.

GMP Manufacturing Milestone: 1,500 Cladribine Films Produced for Human Clinical Trials

BioNxt has completed GMP manufacturing of approximately 1,500 investigational BNT23001 sublingual Cladribine oral dissolvable films intended for its planned human clinical study. Manufacturing activities were completed in October 2026, marking an important step in advancing the Company's proprietary formulation from pharmaceutical development toward clinical evaluation. The films are currently undergoing the required quality control testing and documentation review, with formal batch release pending satisfactory completion of these procedures.

Manufacturing an investigational pharmaceutical product under GMP conditions requires controlled production processes and appropriate quality systems to support product consistency, identity, strength, and purity. The completion of this manufacturing stage therefore represents an important operational milestone in BioNxt's clinical development preparations and supports the Company's broader efforts to establish its proprietary sublingual ODF technology as a versatile drug-delivery platform.

European Clinical Trial Application Submitted: Advancing Toward Human Studies

On October 16, 2026, BioNxt's clinical development partners submitted the CTA and supporting documentation through CTIS, the centralized European platform for clinical trial applications under the European Union's Clinical Trials Regulation. The submission follows the completion of the IMPD announced in August 2026 and builds on the Company's earlier formulation development, comparative preclinical pharmacokinetic evaluations, and local tolerability studies.

The planned clinical study is designed as a randomized, open-label, crossover investigation comparing BioNxt's sublingual Cladribine ODF with Mavenclad®, the approved oral Cladribine tablet formulation. Conducted in healthy adult volunteers, the study is intended to evaluate the pharmacokinetic characteristics and relative bioavailability of BNT23001, including whether systemic Cladribine exposure meets the applicable criteria for bioequivalence to the reference product. Safety and tolerability will also be assessed, with the resulting human data expected to inform subsequent development decisions and the Company's European regulatory strategy.

The CTA is now subject to the applicable regulatory validation, assessment, and authorization procedures. Based on current development planning, BioNxt anticipates that the review process could take approximately three months, although actual timing will depend on the relevant authorities and any requests for additional information. Clinical trial initiation remains contingent upon regulatory authorization, applicable ethics approvals, satisfactory completion of quality control testing, and formal release of the investigational medicinal product.

Transforming Cladribine Delivery: A Patient-Focused Approach to Multiple Sclerosis

BioNxt is developing BNT23001 as a differentiated alternative to conventional Cladribine tablets, an approved treatment for certain relapsing forms of multiple sclerosis. Its proprietary sublingual oral dissolvable film is designed to dissolve under the tongue without water or the need to swallow an intact tablet, potentially simplifying administration for patients experiencing swallowing difficulties. The Company aims to achieve systemic drug exposure comparable to the approved reference medicine while offering a more convenient dosage form.

BioNxt is pursuing a potential European hybrid regulatory pathway that may leverage existing knowledge of Cladribine while requiring additional evidence specific to its formulation. The planned human study will provide important pharmacokinetic data to guide further development and assess the formulation's potential for bioequivalence.

Hugh Rogers, Chief Executive Officer of BioNxt Solutions Inc., commented: "Completing GMP manufacturing and submitting our European clinical trial application mark a major step toward human clinical evaluation of BNT23001. Following extensive formulation development, preclinical testing, and regulatory preparation, we are now approaching a critical phase in our development program."

"Our objective is to make established medicines more convenient and accessible through advanced drug-delivery technologies. Beyond Cladribine, we see significant opportunities to apply our proprietary sublingual platform across additional therapeutic areas, supporting our strategy to build BioNxt into a diversified pharmaceutical development company."

Next Milestone: Regulatory Authorization and Initiation of Human Clinical Studies

With the CTA submitted and GMP manufacturing activities completed, BioNxt's immediate priorities are finalizing quality control testing, securing formal batch release of the investigational Cladribine films, and supporting the European regulatory review process. In parallel, the Company and its clinical development partners will continue operational preparations for the proposed study, including clinical trial material logistics and study-site readiness.

Subject to regulatory authorization and completion of the remaining preparations, BioNxt intends to initiate its comparative human pharmacokinetic and bioequivalence study. The resulting data are expected to support the evaluation of BNT23001's potential as a differentiated Cladribine formulation and inform the Company's subsequent clinical and regulatory development activities.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience innovator advancing next-generation drug delivery technologies designed to improve therapeutic outcomes, patient experience and treatment adherence. The Company's proprietary platform technologies include oral dissolvable films (ODF), transdermal drug delivery systems, oral dosage formulations and a precision oncology platform focused on targeted drug delivery.

BioNxt is advancing a diversified pipeline of patient-centric product candidates for neurological, autoimmune and oncology indications by leveraging innovative drug delivery technologies with established pharmaceutical compounds. The Company's lead development program, BNT23001, is a proprietary sublingual cladribine oral dissolvable film for the treatment of relapsing forms of multiple sclerosis, currently advancing toward human clinical studies under a hybrid regulatory pathway in Europe.

With research and development activities and strategic partnerships across Europe and North America, BioNxt is focused on advancing clinical development, securing intellectual property, and pursuing commercialization through internal development and strategic partnering opportunities.

BioNxt Solutions Inc. is listed on the Canadian Securities Exchange (CSE:BNXT), the OTCQB Venture Market (OTCQB:BNXTF) and the Frankfurt Stock Exchange (FSE:BXT).

For more information, please visit www.bionxt.com.

Investor Relations & Media Contact

Email: [email protected]

Wolfgang Probst
Co-Founder, CFO & Director
Phone: +49 151 25284192

Hugh Rogers
Co-Founder, CEO & Director
Phone: +1 604 250 6162

Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt

Cautionary Statement Regarding "Forward-Looking" Information

This news release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"). These statements are based on management's current expectations, estimates, projections, beliefs and assumptions as of the date of this news release and are subject to known and unknown risks, uncertainties and other factors that could cause actual results or events to differ materially from those expressed or implied.

Forward-looking statements in this news release include, but are not limited to, statements regarding the completion of quality control testing and formal batch release of the Company's investigational Cladribine oral dissolvable films; the validation, assessment, authorization and anticipated review timeline of the European Clinical Trial Application; the initiation, timing, conduct and completion of the planned human pharmacokinetic and bioequivalence study; anticipated pharmacokinetic, bioavailability, bioequivalence, safety and tolerability outcomes; the potential for BNT23001 to provide a differentiated or more convenient alternative to conventional Cladribine tablets; the Company's proposed European hybrid regulatory pathway; further clinical and regulatory development of BNT23001; the advancement of the Company's broader sublingual drug-delivery platform; intellectual property protection; potential commercialization, licensing and strategic partnering opportunities; and the achievement of future development, regulatory and commercial milestones.

Forward-looking statements involve significant risks, uncertainties and assumptions, many of which are beyond the Company's control. These include, without limitation, risks associated with pharmaceutical research and development; investigational product manufacturing, quality control and batch release; clinical trial application review and authorization; clinical trial preparation, recruitment, conduct and completion; pharmacokinetic performance and bioequivalence; unexpected safety findings; regulatory requirements and approvals; reliance on third-party manufacturers, suppliers, contract research organizations and development partners; intellectual property protection and enforcement; financing requirements; competitive technologies; market acceptance; and general economic, financial and capital market conditions.

There can be no assurance that the Clinical Trial Application will be authorized within the anticipated timeframe or at all; that the investigational Cladribine films will successfully complete the required quality control procedures; that the planned clinical study will be initiated or completed as anticipated; that BNT23001 will demonstrate bioequivalence, acceptable safety or the anticipated pharmacokinetic characteristics relative to the reference product; that potential administration advantages will be established in clinical studies; that the proposed European hybrid regulatory pathway will be available or accepted by the relevant regulatory authorities; that required regulatory approvals will be obtained; or that any product candidate will successfully complete development or achieve commercialization. Readers are cautioned not to place undue reliance on these forward-looking statements.

Except as required by applicable securities laws, BioNxt Solutions Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Mavenclad® is an oral tablet prescription medication manufactured and registered as a trademark by Merck KGaA and is not owned by, affiliated with, sponsored by, or associated with BioNxt Solutions Inc.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

D. O'Sullivan--BTZ